Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

China Medical University

Status and phase: Completed; Phase 2

Conditions: Middle Cerebral Artery Infarction; Stroke

Treatments: Procedure: Intercerebral implantation of Autulogous Stem Cells; Drug: convention therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00950521

DOH Approval No:098004365

DMR-96-IRB-145

Details and patient eligibility

About

The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.

Full description

30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.

Enrollment: 30 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 35-70 chronic stroke adult patient,
• with stroke history of more than 6 months, less than 60 months，
• with stable hemiplegia condition, and
• NIHSS (NIH Stroke Scale) score is between 9-20.

Exclusion criteria

• patients aged less than 35 or more than 70,
• hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
• pregnant women,
• impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

PBSC Treatment

Active Comparator group

Description:

Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication

Treatment:

Procedure: Intercerebral implantation of Autulogous Stem Cells

Control

Active Comparator group

Description:

Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication

Treatment:

Drug: convention therapy